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Generated: December 11, 2017

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Zolpidem tartrate - Generic Drug Details

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What are the generic drug sources for zolpidem tartrate and what is the scope of zolpidem tartrate patent protection?

Zolpidem tartrate
is the generic ingredient in seven branded drugs marketed by Magna Pharms, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Biovail Labs Intl, Allied Pharma Inc, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has two hundred and forty-five patent family members in thirty-six countries and six supplementary protection certificates in five countries.

There are thirty-one drug master file entries for zolpidem tartrate. Sixty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for zolpidem tartrate

Tentative approvals for ZOLPIDEM TARTRATE

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET;ORAL
u► Subscribe10MGTABLET;ORAL
u► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Synthon PharmsZOLPIDEM TARTRATEzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL078483-002Jun 6, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncZOLPIDEM TARTRATEzolpidem tartrateTABLET;SUBLINGUAL202657-002Aug 8, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
HikmaZOLPIDEM TARTRATEzolpidem tartrateTABLET;ORAL078129-001Apr 30, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpEDLUARzolpidem tartrateTABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo PharmaZOLPIDEM TARTRATEzolpidem tartrateTABLET;ORAL078413-002May 4, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesZOLPIDEM TARTRATEzolpidem tartrateTABLET;ORAL077288-001Apr 23, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpEDLUARzolpidem tartrateTABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharma GlobalZOLPIDEM TARTRATEzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL204170-001Jan 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Magna PharmsZOLPIMISTzolpidem tartrateSPRAY, METERED;ORAL022196-001Dec 19, 2008► Subscribe► Subscribe
Sanofi Aventis UsAMBIENzolpidem tartrateTABLET;ORAL019908-002Dec 16, 1992► Subscribe► Subscribe
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005► Subscribe► Subscribe
Sanofi Aventis UsAMBIENzolpidem tartrateTABLET;ORAL019908-001Dec 16, 1992► Subscribe► Subscribe
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: zolpidem tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,097,431Methods and compositions for detecting steroids► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► Subscribe
6,676,931 Buccal, polar and non-polar spray or capsule► Subscribe
6,998,110Buccal, polar and non-polar spray or capsule► Subscribe
9,078,816Buccal, polar and non-polar spray containing ondansetron► Subscribe
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system► Subscribe
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: zolpidem tartrate

Country Document Number Estimated Expiration
Canada2816904► Subscribe
Hong Kong1037319► Subscribe
Israel187309► Subscribe
Portugal1115383► Subscribe
European Patent Office1750670► Subscribe
Canada2497268► Subscribe
European Patent Office1675568► Subscribe
World Intellectual Property Organization (WIPO)2006128022► Subscribe
Australia2003262917► Subscribe
South Africa200606411► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZOLPIDEM TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
4Finland► Subscribe
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015 00004Denmark► SubscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Baxter
US Army
Fuji
Covington
Fish and Richardson
McKinsey
Johnson and Johnson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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